Clinical Research Nurse

Nemours; Orlando (FL); On-site; USD 65,000 - 95,000; Full time

Job summary

Nemours seeks a Clinical Research Nurse in Orlando, FL to coordinate oncology studies within NCCBD, screening patients, obtaining consent, educating families, and managing study data and records. You will interface with sponsors, schedule visits, and assist in audits and quality improvement.

Responsibilities include training staff, maintaining data quality, coordinating drug administration with the research pharmacist, and supporting multi-site trials per protocol.

Qualifications

• Bachelor's degree in nursing preferred; ASN will require BSN within 3 years of hire
• 1-3 years experience in clinical research coordination
• Clinical Research Coordinator certification or eligible after 2 years coordination experience

Responsibilities

• Follows SOPs and Good Clinical Practices; prepares documents for sponsors; attends Investigator Meetings.
• Coordinates and conducts studies including Emergent Access/Compassionate use, multi-site trials, Investigator Initiated studies; training manuals.
• Supports NCCBD's NCORP by scheduling visits and ensuring protocol compliance.
• Data gathering, measurements and monitoring of data integrity; maintains multiple study databases; timely data queries.
• Trains nursing staff and coordinates with departments to ensure protocol compliance.
• Reports Serious Adverse Events and follows up on unanticipated problems.
• Maintains study drug accountability in collaboration with the research pharmacist.
• Prepares specimens for shipment to central laboratories; ensures SOPs and documentation accompany samples.
• Coordinates sponsor monitoring activities; completes Case Report Forms and responses to sponsor queries.
• Participates in audits and continuous process improvement initiatives.

Skills

Oncology clinical research

Clinical trial coordination

GCP compliance

Education

Associate degree in Nursing

Bachelor's degree in Nursing preferred

BSN within 3 years of hire

Job description

Nemours is seeking a Clinical Research Nurse to join our team in Orlando, FL.

Clinical Research Nurse

In Oncology supporting NCCBD (Nemours Center for Cancer & Blood Disorders) - coordinates, implements and completes clinical research studies and/or clinical trials by assisting in screening oncology patients, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases, process and shipment of research samples, participation in continuous process improvement initiatives.

Essential Functions:

1. Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned.
2. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals.

Supporting NCCBD's NCORP: NCI Community Oncology Research Program across the Nemours enterprise. Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.

Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.

Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.

Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems.

Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation.

Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples.

Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.

Participates in continuous process improvement initiatives and implementation of outcomes.

Prepares for internal and external audits. Prepares corrective action plans as indicated.

Attendance at and participation in relevant clinical divisional/departmental activities to assure routine administrative procedures are followed. Further attendance at Sponsor Coordinator meetings as needed for study related training.

Requirements:

• Bachelor's degree in nursing preferred; Associate degree in Nursing required. ASN will require obtaining BSN within 3 years of hire date
• 1-3 years experience
• Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience

About Us

Nemours Children's Health is an internationally recognized pediatric health system serving more than 1.7 million patient encounters each year. We deliver care across six states through two freestanding children's hospitals - Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida - along with a network of more than 80 primary, urgent, and specialty care practices and more than 40 hospital partnerships.

Backed by the Nemours Foundation and Alfred I. duPont Trust, our $1.7B nonprofit system is dedicated to improving children's health through clinical care, research, education, advocacy, and prevention. Our Whole Child Health approach focuses equally on prevention and treatment, partnering with communities to help every child thrive.

Inclusion and belonging guide our strategy and growth. We are committed to culturally relevant care, reducing health disparities, and fostering an environment where every associate, patient, and family feels supported and valued.

Learn more at Nemours.org .